Events

Coroflex Blue coronary stent 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 B.Braun Medical 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 날짜
    2005-04-19
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-de-stents-coronaires-coroflex-blue-de-la-societe-b-braun-medical
  • 비고 / 경고
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and France.
  • 데이터 추가 비고
  • 조치
    B.BRAUN Medical withdrew from the market on April 15, 2005 the references and batches specified in the annex, of the medical device called Coroflex Blue coronary stent following two reports concerning a too slow deflation of the balloon .. The company warned directly the recipients (in limited number) of the incriminated lots (15/04/2005) (6 ko) with the attached message (15/04/2005) (9 ko) validated by Afssaps .. This information s address to the directors of health establishments, pharmacists and local correspondents of materiovigilance for dissemination, where appropriate to the departments concerned .. The competent German authority has been informed of this measure by the manufacturer .. Customer mail (15 / 04/2005) (9 KB List of lots concerned (15/04/2005) (6 KB)

Device

Coroflex Blue coronary stent
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    B.Braun Medical

Manufacturer

B.Braun Medical